Breast CancerNCT00003736
MRI for Detecting Cancer in Women Who Are at High Risk of Developing Breast Cancer
A study testing motexafin gadolinium, biopsy and breast imaging study in people with Breast Cancer, run by Abramson Cancer Center at Penn Medicine at 12 sites in 2 countries.
Trial summary
RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for breast cancer. Diagnostic procedures such as MRI may improve the ability to detect breast cancer. Read more about this study
- Who is it for?
- Ages 25 to 120 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- motexafin gadolinium, biopsy and breast imaging study
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Jun 1999to Jun 2002
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Patients at greater than 25% lifetime risk for breast cancer on the basis of family history or a genetic test
- Prior breast cancer allowed if patient meets the greater than 25% lifetime risk
- Patients with greater than 5 years since diagnosis must have at least 50% probability for developing breast cancer by the Couch model or be positive for BRCA1 or BRCA2 mutation
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 25 and over
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No contraindications to MRI scan including patients with pacemakers, magnetic aneurysm clips or other implanted magnetic devices, or severe claustrophobia
- Not pregnant
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States11 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
University of Colorado Cancer Center
Denver, Colorado, 80010
Porter Adventist Hospital
Denver, Colorado, 80210
Hartford Hospital
Hartford, Connecticut, 06102-5037
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
University of Washington Medical Center
Seattle, Washington, 98195-6043
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
About this study
Official title: Pilot Study: High Risk Breast Cancer Screening Pilot Study
RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for breast cancer. Diagnostic procedures such as MRI may improve the ability to detect breast cancer.
PURPOSE: Screening and diagnostic trial to study the effectiveness of MRI scans in women who are at high risk for developing breast cancer.
Read the detailed description
OBJECTIVES:
- Estimate the diagnostic yield and positive predictive value of breast magnetic resonance imaging (MRI) for the detection of cancer in women who are at greater than 25% lifetime risk for developing breast cancer.
- Compare the diagnostic yield and positive predictive value of MRI with conventional breast cancer screening (mammography and physical examination) for the detection of breast cancer in women with a greater than 25% lifetime risk of developing breast cancer.
OUTLINE: All patients receive a physical exam within 90 days of initial MRI scan. Patients undergo a two view screening mammogram within 3 months prior to study entry. Patients undergo an MRI with gadolinium contrast at entry. All lesions identified as suspicious on physical examination, mammography, or MRI undergo a core needle or excisional biopsy.
PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study within 2 years.
- Conditions
- Breast Cancer
- Being tested
- motexafin gadolinium, biopsy, breast imaging study, comparison of screening methods, magnetic resonance imaging
- Keywords
- breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motexafin gadoliniumDrug
biopsyProcedure or surgery
breast imaging studyProcedure or surgery
comparison of screening methodsProcedure or surgery
magnetic resonance imagingProcedure or surgery
study of high risk factorsProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2003 (estimated)
- Study startJun 1999
- Primary completionJun 2002
- Study completionJun 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Mitchell Schnall, PhD, Study chair, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003736
- Sponsor's protocol ID
- CDR0000066851
- Other IDs
- UPCC-ACR-6884, UPCC -IBMC-6884
- Status last verified
- Sep 2019
- First submitted
- 1 Nov 1999
- Last updated
- 24 Sep 2019
- Results posted
- No
Publications
Lehman CD, Blume JD, Thickman D, Bluemke DA, Pisano E, Kuhl C, Julian TB, Hylton N, Weatherall P, O'loughlin M, Schnitt SJ, Gatsonis C, Schnall MD. Added cancer yield of MRI in screening the contralateral breast of women recently diagnosed with breast cancer: results from the International Breast Magnetic Resonance Consortium (IBMC) trial. J Surg Oncol. 2005 Oct 1;92(1):9-15; discussion 15-6. doi: 10.1002/jso.20350.
PubMed 16180217Lehman CD, Blume JD, Weatherall P, Thickman D, Hylton N, Warner E, Pisano E, Schnitt SJ, Gatsonis C, Schnall M, DeAngelis GA, Stomper P, Rosen EL, O'Loughlin M, Harms S, Bluemke DA; International Breast MRI Consortium Working Group. Screening women at high risk for breast cancer with mammography and magnetic resonance imaging. Cancer. 2005 May 1;103(9):1898-905. doi: 10.1002/cncr.20971.
PubMed 15800894
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: High Risk Breast Cancer Screening Pilot Study
- ClinicalTrials.gov ID
- NCT00003736
- Acronym / sponsor ID
- CDR0000066851
- Conditions
- Breast Cancer
- Keywords
- breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 1999
- Primary completion
- Jun 2002 (actual)
- Study completion
- Jun 2002 (actual)
- First posted
- 20 Aug 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for breast cancer. Diagnostic procedures such as MRI may improve the ability to detect breast cancer.
PURPOSE: Screening and diagnostic trial to study the effectiveness of MRI scans in women who are at high risk for developing breast cancer.
Detailed description
OBJECTIVES:
- Estimate the diagnostic yield and positive predictive value of breast magnetic resonance imaging (MRI) for the detection of cancer in women who are at greater than 25% lifetime risk for developing breast cancer.
- Compare the diagnostic yield and positive predictive value of MRI with conventional breast cancer screening (mammography and physical examination) for the detection of breast cancer in women with a greater than 25% lifetime risk of developing breast cancer.
OUTLINE: All patients receive a physical exam within 90 days of initial MRI scan. Patients undergo a two view screening mammogram within 3 months prior to study entry. Patients undergo an MRI with gadolinium contrast at entry. All lesions identified as suspicious on physical examination, mammography, or MRI undergo a core needle or excisional biopsy.
PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study within 2 years.
Study design
- Primary purpose
- Screening
Who may qualify
- Ages
- 25 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| motexafin gadolinium | Drug | – |
| biopsy | Procedure or surgery | – |
| breast imaging study | Procedure or surgery | – |
| comparison of screening methods | Procedure or surgery | – |
| magnetic resonance imaging | Procedure or surgery | – |
| study of high risk factors | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
- Results publication: PubMed 16180217Lehman CD, Blume JD, Thickman D, Bluemke DA, Pisano E, Kuhl C, Julian TB, Hylton N, Weatherall P, O'loughlin M, Schnitt SJ, Gatsonis C, Schnall MD. Added cancer yield of MRI in screening the contralateral breast of women recently diagnosed with breast cancer: results from the International Breast Magnetic Resonance Consortium (IBMC) trial. J Surg Oncol. 2005 Oct 1;92(1):9-15; discussion 15-6. doi: 10.1002/jso.20350.
- Results publication: PubMed 15800894Lehman CD, Blume JD, Weatherall P, Thickman D, Hylton N, Warner E, Pisano E, Schnitt SJ, Gatsonis C, Schnall M, DeAngelis GA, Stomper P, Rosen EL, O'Loughlin M, Harms S, Bluemke DA; International Breast MRI Consortium Working Group. Screening women at high risk for breast cancer with mammography and magnetic resonance imaging. Cancer. 2005 May 1;103(9):1898-905. doi: 10.1002/cncr.20971.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchell Schnall, PhD study chair
Abramson Cancer Center at Penn Medicine
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing motexafin gadolinium, biopsy and breast imaging study in people with Breast Cancer, run by Abramson Cancer Center at Penn Medicine at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003736, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2019.